The Effects of Milk Protein Versus Soy Protein on Essential Omega-3 Fatty Acid Metabolism

NCT05820256 | Active Not Recruiting DMC

• 1 other identifier: Dietary Proteins and Omega-3s
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

Dairy products provide macronutrients, vitamins, and minerals that are important for health and development. Despite this, many Canadians now eat fewer dairy products and are instead consuming more non-dairy alternatives, such as soy. Some of this is because of misconceptions about the effects of dairy on health. However, the study investigators hypothesize that, compared to soy, dairy may actually improve a person's health due to its effects on the enzymes in the body that make omega-3 fatty acids, such as EPA and DHA. The goal of this study is to examine omega-3 metabolism in men and women consuming either milk or soy protein. Briefly, this study will determine if the consumption of milk or soy protein differentially impacts blood EPA and DHA levels, the synthesis of EPA and DHA, fatty acid oxidation, and omega-3 fat absorption from the gut. It is anticipated that the findings from this novel and innovative research project will provide high quality evidence to support a previously unappreciated protective effect of dairy for human health and development.

Conditions

Nutrition, Healthy

Keywords

omega-3 metabolism; ALA; EPA; DHA; fatty acid desaturase; fat oxidation

Outcome Measures

Primary Outcomes (1)

• Change in plasma EPA and DHA content from baseline

  The change in plasma EPA and DHA content from baseline will be determined by using gas chromatography at multiple time points during the 31-day dietary intervention in which study participants consume 2 smoothies per day containing either a milk protein isolate (MPI) or a soy protein isolate (SPI).

  Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31

Secondary Outcomes (4)

• Change in EPA and DHA synthesis from baseline

  Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31

• Change in whole blood gene expression from baseline

  Measured on days: 0 (baseline) and 31

• Change in fatty acid oxidation from baseline

  Measured on days: 0 (baseline), 15, 30, and 31

• Change in ALA absorption from balance

  Measured on days: 0 (baseline) and 31

Study Arms (2)

Milk Protein Isolate (MPI)

EXPERIMENTAL

Study participants in the MPI group will consume 2 smoothies per day for 31 days, where each smoothie provides 300 kcal in total, composed of 45% from carbohydrate (maltodextrin), 20% from protein (milk protein isolate) and 35% from fat (a blend of flaxseed, safflower, and coconut oils). Each smoothie will be mixed with water up to volume of 250mL. Individuals in this group will not consume soy-containing beverages and foods during the 31-day study.

Dietary Supplement: Milk Protein Isolate (MPI)

Soy Protein Isolate (SPI)

EXPERIMENTAL

Study participants in the SPI group will consume 2 smoothies per day for 31 days, where each smoothie provides 300 kcal in total, composed of 45% from carbohydrate (maltodextrin), 20% from protein (soy protein isolate) and 35% from fat (a blend of flaxseed, safflower, and coconut oils). Each smoothie will be mixed with water up to volume of 250mL. Individuals in this group will not consume dairy-containing beverages and foods during the 31-day study.

Dietary Supplement: Soy Protein Isolate (SPI)

Interventions

Milk Protein Isolate (MPI) DIETARY_SUPPLEMENT

Study participants will consume two smoothies per day containing a milk protein isolate (MPI) for 31 days.

Milk Protein Isolate (MPI)

Soy Protein Isolate (SPI) DIETARY_SUPPLEMENT

Study participants will consume two smoothies per day containing a soy protein isolate (SPI) for 31 days.

Soy Protein Isolate (SPI)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult men and pre-menopausal women
• Must be able to consume soy and dairy beverages and foods
• Sufficient level of education to understand study procedures and be able to communicate with clinical staff

You may not qualify if:

• Diabetic
• Body mass index greater than 35 kg/m2
• Pregnant or lactating
• Neuropsychiatric disorders (major depression, schizophrenia)
• Digestive disorders
• Inflammatory disease
• Cardiovascular disease
• Use of omega-3 supplements within the last 3 months
• Regular consumption of oily fish
• Allergies/sensitivities to dairy and/or soy food products
• Use of lipid-lowering or digestive medication

Sponsors & Collaborators

• University of Guelph: lead
• Université de Sherbrooke: collaborator

Study Sites (2)

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Related Publications (1)

• Gonzalez-Soto M, Abdelmagid SA, Ma DWL, El-Sohemy A, Mutch DM. Soy Consumption, but Not Dairy Consumption, Is Inversely Associated with Fatty Acid Desaturase Activity in Young Adults. Nutrients. 2021 Aug 17;13(8):2817. doi: 10.3390/nu13082817.

  PMID: 34444977 BACKGROUND

MeSH Terms

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study participants will be block randomized by gender into one of two groups for a parallel-arm trial.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 19, 2023
• Study Start: September 1, 2023
• Primary Completion: September 18, 2024
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)